| 注册分类6化学药品立题合理性相关问题的讨论 |
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| 引用本文： | 许真玉.注册分类6化学药品立题合理性相关问题的讨论[J].国际药学研究杂志,2014,0(4):429-431. |
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| 作者姓名： | 许真玉 |
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| 作者单位： | 许真玉(国家食品药品监督管理总局药品审评中心,北京,100038)； |
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| 摘 要： | 注册分类6的化学药品在注册申报过程中暴露了一些立题方面的问题。作为药物研发者，必须追踪药物最新的安全有效性和质量可控性信息，为药物研究开发提供扎实的立题基础。本文结合日常药品审评工作，从化合物、剂型、规格等方面对注册分类6化学药品立题合理性相关问题进行讨论。
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| 关 键 词： | 化学药品 立题 合理性 |
Issues about the rationality of subject selection in chemical generic drug registration application：a discussion |
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| XU Zhen-yu.Issues about the rationality of subject selection in chemical generic drug registration application：a discussion[J].Foreign Medical Sciences(Section of Pharmarcy),2014,0(4):429-431. |
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| Authors: | XU Zhen-yu |
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| Institution: | XU Zhen-yu (Center for Drug Evaluation, China Food and Drug Administration ,Beijing 100038, China) |
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| Abstract: | Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor＇s responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength. |
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| Keywords: | chemical generic drug subject selection rationality |
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